BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    GE LOGIQ 5

    FDA 510(k)
    FDA Class 2 ·Radiology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0140070·T-Handle, T30, Locking Cap Adjuster

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650368·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650375·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033562864·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650344·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650351·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650382·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00887661650399·

    POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·July 19, 2018

    HEARTSINE SAMARITAN 300P AND PAD-PAK K014067

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·March 7, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, DR·Product code DYG·March 14, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·March 27, 2024